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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Big Pharma Faces Prospect of Big Fines in 2012

Posted 23 January 2012 | By

Some of the world's largest pharmaceutical companies are facing "costly settlements" during 2012 thanks to aggressive investigations and enforcement by US agencies and a wide-ranging list of improper activities allegedly perpetrated by the pharmaceutical companies, according to an analysis by The Financial Times.

The Financial Times analysis notes that US-based companies are the target of the most prosecutions worldwide and that healthcare companies accounted for 12% of all enforcement actions since 1977. However, this may be because heavily regulated industries have "sophisticated compliance teams" that are more comfortable with disclosing their lack of adherence to regulations or laws, said Alexandra Wrage of the corruption-tracking non-profit Trace International.

An unnamed pharmaceutical executive expressed frustration that companies are often pressured to settle with the government due to threats against their government contracts or the costs associated with negative publicity.

The enforcement is largely coming from the US and other established western markets, says Wrage, adding that other countries are loathe to prosecute their own national pharmaceutical companies for fear of losing their "competitive advantage."

The wave of prosecutions and possible settlements could make it more difficult for the industry to claim the benefits of self-regulation, notes The Financial Times. Without real penalties, there is little pressure to adhere to ethical behavior aside from a disdain of negative publicity.